Semi-Annual Medical Device Sterilization Conference

December 10-11, 2019 | San Diego, CA

Andaz San Diego Hotel

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DAY ONE | TUESDAY, OCTOBER 29

8:00 REGISTRATION & WELCOME COFFEE

8:30 CHAIRPERSON’S OPENING REMARKS
Art Harris, Sterilization Manager, COOK MEDICAL

8:45 EVALUATING THE STATE OF ETHYLENE OXIDE STERILIZATION

  • Current concerns surrounding EO sterilization
    • Worker exposure
    • Neonates
    • Environmental
  • Integration of ISO 10993-7 and 11135 in EO sterilization
  • Optimizing the use of EO in sterilization of medical products
    • Minimized EO use
    • Cycle validation
    • Extended aeration time
    • Re-calibrated process challenges
    • Efficient chamber configuration
  • Ensuring compliance under optimized validation approaches
  • Impact of reduced EO sterilization capacity on overall industry

MODERATOR: Ken Gordon, STERIS CORPORATION

PANELISTS:
Tim Carlson, BECTON DICKINSON

Rod Parker, STRYKER

 

9:30 MITIGATING RISKS THROUGH ENHANCED EO STERILIZATION TECHNIQUES
As regulations are becoming more rigorous and EO residual acceptance rates are being lowered, industry experts are looking to novel EO sterilization optimization approaches focused on risk management and process maintenance. This short-form case study will explore and provide insight into the benefits accrued through the deployment of a manifold, novel approach to optimization while maintaining process integrity and sterility assurance outcomes equitable to traditional methods.

Martin Byrne, Director of Sterilization Technology, ZIMMER BIOMET

 

10:15 COFFEE & NETWORKING BREAK

 

10:45 SCIENTIFIC ISSUES IN THE REGULATORY ASSESSMENT OF EO CANCER RISK

  • Dose-response modeling issues
  • Endogenous & carcinogenic doses
  • Risk: Population & key worker estimates
  • Scientific weight-of-evidence

Joseph Haney, Toxicologist, TEXAS COMMISSION ON ENVIRONMENTAL QUALITY

 

11:30 INTEGRATING STERILIZATION AND QUALITY ENGINEERS IN PRODUCT DESIGN
All too often, sterilization and packaging considerations are almost an afterthought in the development process. Much of this is because there is a lack of awareness in the value that these disciplines can bring. If brought in early, sterilization and packaging can have a positive impact on quality, COGs and most importantly for development, acceleration of timelines. Brought in late, these areas could result in increase in costs and timelines. This discussion will provide talking points for the sterilization professionals to ensure inclusion early on in the developmental process.

Stan Lam, Sr. Process and Technology Development, STRYKER

 

12:15 LUNCHEON FOR SPEAKERS, SPONSORS & ATTENDEES

 

1:45 RISK ASSESSMENT & BIOCOMPATIBILITY: ALIGNMENT UNDER ISO 10993
FDA’s January 2019 consensus on ISO 10933-1 specifies the requirement for a comprehensive biological evaluation of all devices pending 510(k) pre-market approval. This new guidance represents not only a heightened level of regulatory scrutiny, but also implies a technically intensive and refined multi-disciplinary approach to biocompatibility testing and comprehension thereof on a device-specific basis. As such, device manufacturers and sterilization professionals are moving to integrate interpretive tools and practices to best ensure compliance under a device-specific regulatory schema.

  • Successful device classification and risk assessment
    • ISO 10993-17 on leachable substances
    • ISO 10993-18 on chemical composition
  • Return of negative biocompatibility results
  • Interpreting and troubleshooting these results

Pete Seiler, Principal Biocompatibility Engineer, WRIGHT MEDICAL

 

2:30 ALIGNMENT OF STERILIZATION WITH QUALITY MANAGEMENT SYSTEMS & ISO 13485
Global regulatory authorities including the FDA require that medical device corporations align sterilization processes with quality management systems, and have provided a guidance and framework through the internationally accepted ISO 13485. While comprehensive in nature, ISO 13485 must be interpreted and implemented across each unique corporation, resulting in variability in practical processes and method of integration. As quality systems and validation requirements for sterilization continue to increase, executives must consider the steps taken to meet increasing quality regulation demands.

  • Establishing baseline bioburden prior to device sterilization
  • Life Cycle Management
  • Validation of new sterilization cycles & process equivalency
  • Recommended frequency of sterilization validation tests
  • Determining method of testing to validate sterilization process

Samantha Hodge, CISS-EO, RM, Manager, Microbiology-Sterilization, MEDTRONIC

 

3:00 COFFEE & NETWORKING BREAK

 

3:30 INDUSTRY APPLICATION OF SUCCESSFUL DEVICE APPROVAL UTILIZING PARAMETRIC RELEASE

  • Processes supporting migration to parametric release
  • Challenges parametric release approval processes
  • Considerations in auxiliary validation in parametric release
  • Evidentiary requirements to support regulatory clearance

Fabiano Andreazza, BECTON DICKINSON

Steven Douglas, BECTON DICKINSON

 

4:15 NOTIFIED BODY PERSPECTIVE ON PARAMETRIC RELEASE STERILITY ASSURANCE
In order to obtain market clearance, medical device manufactures must provide documentation validating the sterilization process and outcome of terminal sterilization, which has traditionally taken the form of a biological indicator sterility test. To streamline approval processes, the agency is now permitting the use of process records or parametric release in lieu of traditional tests, saving time and resources for medical device firms in the final stages of approval, for a number of sterilization modalities. Discussion surrounding current guidance and best practices for industry executives will provide insights for those considering this type of regulatory submission.

Mike Harding, Medical Device Sterilization SME, DEKRA

 

5:00 END OF DAY ONE CONFERENCE